Terumo Glidesheath Sheath Recall: Sterile Packaging Risk
Terumo recalls Glidesheath Slender Hydrophilic Coated Introducer Sheaths with potential sterile packaging breaches. Affected lots include 161019, 161108, 161215, 170112, 170213, 170314. Contact for remedy.
Lower-risk recall
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Contact the company
What happened, in plain English
Terumo recalls a specific type of medical sheath due to a small risk of sterile packaging breaches. This could compromise the sheath's sterility, potentially causing infections during medical procedures. Read more at govinfonow.com/recall/73900-terumo-glidesheath-sheath-recall-sterile-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73900-terumo-glidesheath-sheath-recall-sterile-packaging-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0230-2018
Cite this page
“Terumo Glidesheath Sheath Recall: Sterile Packaging Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73900-terumo-glidesheath-sheath-recall-sterile-packaging-risk. Based on FDA recall #Z-0230-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0230-2018%22&limit=1).
Why it’s dangerous
A small percentage of the sheaths (0.01%) had packaging that didn't seal properly. This breach could allow contamination, risking infection during medical procedures if the sheath is not sterile.
Who’s affected
Healthcare professionals using the Glidesheath Slender Hydrophilic Coated Introducer Sheath for medical procedures. Patients receiving procedures with this sheath may be at risk of infection.
How to tell if you have this one
Check the product code RM*RS7F16PA and lot numbers 161019, 161108, 161215, 170112, 170213, or 170314. The sheath is sterile and requires a prescription.
- Brand
Terumo- Category
Medical device
All 17 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Canada
| Recall number | Product, codes & lots |
|---|---|
| Z-0214-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY; Lot 161104 |
| Z-0215-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY; Lots 161116, 170113 |
| Z-0216-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY; Lot 161111 |
| Z-0217-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY; Lot s161118, 161206, 170119 |
| Z-0218-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY; Lot 170316 |
| Z-0219-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY; Lot 161110, 161214, 170119 |
| Z-0220-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY; Lot s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023 |
| Z-0221-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY; Lot s 161209, 170118, 170215, 170317 |
| Z-0222-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY; Lot s 161018, 161116, 161117, 161213, 161214, 170118, 170119 |
| Z-0223-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY; Lot s 161019, 161115, 161212, 170112 |
| Z-0224-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY; Lot s 161107, 170209, 170307, 170406 |
| Z-0225-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY; Lot 170113 |
| Z-0226-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY; Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201 |
| Z-0227-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY; Lot s 161116, 161213, 170117, 170213, 170308 |
| Z-0228-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY; Lot s 161115, 161130, 161207, 170116 |
| Z-0229-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY; Lot s 161109, 161216, 170118, 170126 |
| Z-0230-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY; Lot s 161019, 161108, 161215, 170112, 170213, 170314 |
What to do — step by step
Check Product Lot Number
Look for lot numbers 161019, 161108, 161215, 170112, 170213, or 170314 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0230-2018 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0230-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.